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Sunquest Information Systems Recalls
9 recalls on record · August 22, 2012 to November 14, 2012 · Medical Devices
November 14, 2012Medical DevicesFDA
Sunquest Information Systems, Inc. recalls Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Hazard: The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
November 14, 2012Medical DevicesFDA
Sunquest Information Systems, Inc. recalls Sunquest Laboratory, version 7.0 not available
Hazard: Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.
October 24, 2012Medical DevicesFDA
Sunquest Information Systems, Inc. recalls Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Hazard: Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
September 19, 2012Medical DevicesFDA
Sunquest Information Systems, Inc. recalls Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunque
Hazard: Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event
September 5, 2012Medical DevicesFDA
Sunquest Information Systems, Inc. recalls Sunquest Laboratory LabAccess Results Workstation (LARS)
Hazard: The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.
September 5, 2012Medical DevicesFDA
Sunquest Information Systems, Inc. recalls Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Hazard: The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.
August 29, 2012Medical DevicesFDA
Sunquest Information Systems, Inc. recalls Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Hazard: Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.
August 29, 2012Medical DevicesFDA
Sunquest Information Systems, Inc. recalls Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Hazard: In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
August 22, 2012Medical DevicesFDA
Sunquest Information Systems, Inc. recalls Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Hazard: In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (<Y>/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or